Phase I Biomarker Study (BMS-936558)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01358721
First received: May 20, 2011
Last updated: July 23, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.


Condition Intervention Phase
Renal Cell Carcinoma
Drug: BMS-936558 (Anti-PD-1)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Exploratory Study to Investigate the Immunomodulatory Activity of Various Dose Levels of Anti Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Subjects With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Immunomodulatory activity as measured by the functional and phenotypic characterization of peripheral immune cells, modulation/changes in soluble factors, and the characterization of tumor immune infiltrates and the expression of tumor markers [ Time Frame: Biomarker samples will be collected prior to the first study treatment through up to 24 weeks following initiation of study treatment ] [ Designated as safety issue: No ]
    Immunomodulation across the 4 treatment arms will be evaluated to explore these measures at multiple doses


Secondary Outcome Measures:
  • Safety and tolerability of BMS-936558 as measured by the incidence and severity of adverse events [ Time Frame: Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (at progression of disease, toxicities requiring discontinuation, withdrawal of consent or study closure) ] [ Designated as safety issue: Yes ]
  • Progression free survival in the BMS-936558 arms [ Time Frame: Progression free survival will be assessed in each individual treatment arm by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  • The tumor response rate in the BMS-936558 arms as assessed by the Investigator assessment of best overall response [ Time Frame: Up to 22 months after study start ] [ Designated as safety issue: No ]
    The tumor response rate will be assessed on all subjects at the time they discontinue study treatment by the Investigators assessment of best overall response for a subject

  • Overall response rate for BMS-936558 as assessed by the number of subjects which demonstrate an objective response divided by the total number of treated subjects with measurable disease at baseline [ Time Frame: response rate will be assessed by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  • Disease control rate for BMS-936558 as measured by the number of subjects with an objective response + the number of subjects with stable disease divided by the total number of treated subjects with measurable disease at baseline [ Time Frame: disease control will be assessed by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  • Duration of objective response for BMS-936558 as measured by the time when the criteria for an objective response are first met until the date of documented disease progression or death [ Time Frame: Duration of response will be assessed by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  • Duration of stable disease for BMS-936558 as measured in subjects whose best overall response is stable disease as the time from baseline until the date of documented disease progression or death [ Time Frame: Duration of response will be assessed by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity of BMS-936558 as measured by the detection of human antibodies against BMS-936558 [ Time Frame: Serum sample collected at baseline, 12 weeks following initiation of study treatment; and during the first 2 follow-up visits in the follow-up phase ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: BMS-936558 Drug: BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response
Experimental: Arm 2: BMS-936558 Drug: BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 2 mg/kg, Every 3 weeks, Indefinitely depending on response
Experimental: Arm 3: BMS-936558 Drug: BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response
Experimental: Arm 4: BMS-936558
(treatment naive)
Drug: BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response

Detailed Description:

Intervention Model: Parallel Dose Comparison

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Women and men ≥ 18 years of age.
  • Histologic confirmation of renal cell carcinoma with a clear cell component.
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
  • Tumor sites that can be accessed for repeat biopsies at acceptable clinical risk.
  • Previously treated subjects must have failed at least 1 prior anti-angiogenic agent and can have a maximum of 3 prior systemic treatments for renal cell cancer.
  • Subjects in the treatment naive arm cannot have received prior systemic therapy for their renal cell carcinoma.

Exclusion Criteria:

  • Active or progressing brain metastases.
  • Active concomitant.
  • Active or history of autoimmune disease.
  • Active use of systemic corticosteroids.
  • Prior therapy with Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), anti Programmed death-1 (anti-PD1), anti Programmed death ligand 1 (anti-PD-L1), anti Programmed death ligand 2 (anti-PD-L2), anti-CD137, anti-CD40, anti-OX40 antibodies.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358721

Locations
United States, California
Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
University Of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Maryland
The Bunting-Blaustein Cancer Research Building
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Inst
Boston, Massachusetts, United States, 02215
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Providence Portland Med Ctr
Portland, Oregon, United States, 97213
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Upmc Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232
United States, Wisconsin
University Of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
France
Local Institution
Villejuif Cedex, France, 94805
Spain
Local Institution
Pamplona, Spain, 31192
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharma USA Inc
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01358721     History of Changes
Other Study ID Numbers: CA209-009, 2011-005379-18
Study First Received: May 20, 2011
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014